MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for KANGAROO FEEDING TUBE WITH IRIS TECHNOLOGY 461055E manufactured by Cardinal Health, Inc..
[184279559]
Feeding tube began leaking at the y connector. This has been an ongoing problem with these tubes. It has to be removed and replaced whenever this happens. Manufacturer response for 10 fr. Kangaroo feeding tube with iris technology, covidien (per site reporter). Nothing else.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859507 |
| MDR Report Key | 9859507 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-10 |
| Report Date | 2020-02-18 |
| Date Reported to FDA | 2020-02-18 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KANGAROO FEEDING TUBE WITH IRIS TECHNOLOGY |
| Generic Name | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
| Product Code | KNT |
| Date Received | 2020-03-20 |
| Model Number | 461055E |
| Catalog Number | 461055E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 300 SOUTH RIVERSIDE PLAZA CHICAGO IL 60606 US 60606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |